Non-invasive ultrasonic body contouring

ABSTRACT

A methodology and system for lysing adipose tissue including directing ultrasonic energy at a multiplicity of target volumes within the region, which target volumes contain adipose tissue, thereby to selectively lyse the adipose tissue in the target volumes and generally not lyse non-adipose tissue in the target volumes and computerized tracking of the multiplicity of target volumes notwithstanding movement of the body.

REFERENCE TO COMPUTER PROGRAM LISTING APPENDIX

A computer program listing appendix is submitted herewith on one compactdisc and one duplicate compact disc. The total number of compact discsincluding duplicates is two. The files on the compact disc are softwareobject code for carrying out a preferred embodiment of the invention.Their names, dates of creation, directory locations, and sizes in bytesare:

-   -   Directory apndx-A containing file TRACKOBJ.HEX (Appendix A) of        Oct. 25, 2001 and of length 233,286 bytes.

The files are referred to herein as Appendix A. The material on thecompact discs is incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to lipolysis generally and moreparticularly to ultrasonic lipolysis.

BACKGROUND OF THE INVENTION

The following U.S. Pat. Nos. are believed to represent the current stateof the art: U.S. Pat. Nos. 4,986,275; 5,143,063; 5,143,073; 5,209,221;5,301,660; 5,431,621; 5,507,790; 5,526,815; 5,884,631; 6,039,048;6,071,239; 6,113,558; 6,206,873

SUMMARY OF THE INVENTION

The present invention seeks to provide improved apparatus andmethodology for ultrasonic lipolysis.

There is thus provided in accordance with a preferred embodiment of thepresent invention a method for lysing adipose tissue including the stepsof:

-   -   directing focussed ultrasonic energy at a target volume in a        region of a body containing adipose tissue; and    -   modulating the focussed ultrasonic energy so as to selectively        lyse the adipose tissue in the target volume and generally not        lyse non-adipose tissue in the target volume.

Additionally in accordance with a preferred embodiment of the presentinvention, there is provided a method for lysing adipose tissueincluding the steps of:

generating, at a source outside a body, ultrasonic energy whichselectively generally lyses adipose tissue and generally does not lysenon-adipose tissue; and

directing the ultrasonic energy, from the source outside the body, at atarget volume of a body containing adipose tissue.

Further in accordance with a preferred embodiment of the presentinvention there is provided a method for lysing adipose tissue includingthe steps of:

defining a region in a body at least partially by detecting spatialindications on the body; and

directing ultrasonic energy at a multiplicity of target volumes withinthe region, which target volumes contain adipose tissue, thereby toselectively lyse the adipose tissue in the target volumes and generallynot lyse non-adipose tissue in the target volumes.

Additionally in accordance with a preferred embodiment of the presentinvention, there is provided a method for lysing adipose tissueincluding the steps of:

directing ultrasonic energy at a multiplicity of target volumes withinthe region, which target volumes contain adipose tissue, thereby toselectively lyse the adipose tissue in the target volumes and generallynot lyse non-adipose tissue in the target volumes; and

computerized tracking of the multiplicity of target volumesnotwithstanding movement of the body.

There is additionally provided in accordance with a preferred embodimentof the present invention apparatus for lysing adipose tissue including:

a focussed ultrasonic energy director, directing focussed ultrasonicenergy at a target volume in a region of a body containing adiposetissue; and

a modulator, cooperating with the energy director to produce a focussedultrasonic energy so as to selectively lyse the adipose tissue in thetarget volume and generally not lyse non-adipose tissue in the targetvolume.

There is further provided in accordance with a preferred embodiment ofthe present invention apparatus for lysing adipose tissue including:

a source outside a body generating ultrasonic energy;

an ultrasonic energy director, which employs the ultrasonic energy toselectively generally lyse adipose tissue and generally not lysenon-adipose tissue in a target volume of a body containing adiposetissue.

There is additionally provided in accordance with a preferred embodimentof the present invention apparatus for lysing adipose tissue includingthe steps of:

a region definer, defining a region in a body at least partially bydetecting spatial indications on the body; and

a director, directing ultrasonic energy at a multiplicity of targetvolumes within the region, which target volumes contain adipose tissuethereby to selectively lyse the adipose tissue in the target volumes andgenerally not lyse non-adipose tissue in the target volumes.

There is still further provided in accordance with a preferredembodiment of the present invention apparatus for lysing adipose tissueincluding:

a director, directing ultrasonic energy at a multiplicity of targetvolumes within the region, which target volumes contain adipose tissue,thereby to selectively lyse the adipose tissue in the target volumes andgenerally not lyse non-adipose tissue in the target volumes; and

computerized tracking functionality providing computerized tracking ofthe multiplicity of target volumes notwithstanding movement of the body.

Preferably, directing focussed ultrasonic energy generally preventslysis of tissue outside of the target volume.

In accordance with a preferred embodiment of the present invention, themethod also includes ultrasonic imaging of the region at least partiallyconcurrently with directing the focussed ultrasonic energy at the targetvolume.

Preferably, directing includes positioning at least one ultrasonictransducer relative to the body in order to direct the focussedultrasonic energy at the target volume.

The directing may also include varying the focus of at least oneultrasonic transducer in order to direct the focussed ultrasonic energyat the target volume. Varying the focus may change the volume of thetarget volume, and/or the distance of the target volume from the atleast one ultrasonic transducer.

The directing may also include positioning at least one ultrasonictransducer relative to the body in order to direct the focussedultrasonic energy at the target volume.

The method preferably also includes sensing ultrasonic energy couplingto an external surface of the body adjacent the target volume.

The method preferably additionally includes sensing of cavitation at thetarget volume.

Preferably, directing takes place from an ultrasonic transducer locatedoutside of the body.

In accordance with a preferred embodiment of the present invention, theultrasonic energy has a frequency in a range of 50 KHz-1000 KHz, morepreferably in a range of 100 KHz-500 KHz, and most preferably in a rangeof 150 KHz-300 KHz.

Preferably, the modulating provides a duty cycle between 1:2 and 1:250,more preferably between 1:5 and 1:30 and most preferably between 1:10and 1:20.

In accordance with a preferred embodiment of the present invention, themodulating provides between 2 and 1000 sequential cycles at an amplitudeabove a cavitation threshold, more preferably between 25 and 500sequential cycles at an amplitude above a cavitation threshold and mostpreferably between 100 and 300 sequential cycles at an amplitude above acavitation threshold.

Preferably, the modulating includes modulating the amplitude of theultrasonic energy over time.

Preferably, directing includes directing focussed ultrasonic energy at amultiplicity of target volumes in a time sequence.

In accordance with a preferred embodiment of the present invention,directing includes directing focussed ultrasonic energy at plural onesof the multiplicity of target volumes at times which at least partiallyoverlap.

Preferably, at least some of the multiplicity of target volumes at leastpartially overlap in space.

In accordance with a preferred embodiment of the present invention, themethod includes defining the region by marking at least one surface ofthe body. The method may also include defining the region by selectingat least one depth in the body and/or by detecting adipose tissue in thebody and/or by detecting non-lysed adipose tissue.

Preferably, directing also includes defining the target volumes as unitvolumes of non-lysed adipose tissue within the region.

In accordance with a preferred embodiment of the present invention,modulating the ultrasonic energy so as to selectively lyse the adiposetissue in the multiplicity of target volumes proceeds sequentially intime wherein selective lysis of adipose tissue in each target volumetakes place only following detection of non-lysed adipose tissuetherein.

Preferably, the method also includes computerized tracking of themultiplicity of target volumes notwithstanding movement of the body.

Preferably, the computerized tracking includes sensing changes in theposition of markings on the body and employing sensed changes fortracking the positions of the target volumes in the body.

Preferably, the modulation provides a decreasing amplitude over timewhich exceeds a cavitation threshold.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more fully fromthe following detailed description, taken in conjunction with thedrawings in which:

FIG. 1 is a simplified pictorial illustration of the general structureand operation of ultrasonic lipolysis apparatus constructed andoperative in accordance with a preferred embodiment of the presentinvention;

FIG. 2 is a simplified block diagram illustration of a preferred powersource and modulator showing a pattern of variation of ultrasonicpressure over time in accordance with a preferred embodiment of thepresent invention;

FIGS. 3A and 3B are simplified pictorial illustrations of the appearanceof an operator interface display during normal operation and faultyoperation respectively;

FIG. 4 is a simplified block diagram illustration of an ultrasoniclipolysis system constructed and operative in accordance with apreferred embodiment of the present invention; and

FIGS. 5A, 5B and 5C are together a simplified flowchart illustratingoperator steps in carrying out lipolysis in accordance with a preferredembodiment of the present invention; and

BRIEF DESCRIPTION OF SOFTWARE APPENDIX

Appendix A is software listing of computer software is object code on aCD ROM for carrying out a preferred embodiment of the invention inaccordance with the best mode known to the inventors.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Reference is now made to FIG. 1, which is a simplified pictorialillustration of the general structure and operation of ultrasoniclipolysis apparatus constructed and operative in accordance with apreferred embodiment of the present invention. As seen in FIG. 1, anultrasonic energy generator and director, such as an ultrasonictransducer 10, disposed outside a body, generates ultrasonic energywhich, by suitable placement of the transducer 10 relative to the body,is directed to a target volume 12 inside the body and is operative toselectively generally lyse adipose tissue and generally not lysenon-adipose tissue in the target volume.

A preferred embodiment of ultrasonic energy generator and directoruseful in the present invention comprises an ultrasonic therapeutictransducer 13 including a curved phased array 14 of piezoelectricelements 15, typically defining a portion of a sphere or of a cylinder,and having conductive coatings 16 on opposite surfaces thereof. Thepiezoelectric elements 15 may be of any suitable configuration, shapeand distribution. An intermediate element 18, formed of a material, suchas polyurethane, which has acoustic impedance similar to that of softmammalian tissue, generally fills the curvature defined by phased array14 and defines a contact surface 20 for engagement with the body,typically via a suitable coupling gel (not shown). Contact surface 20may be planar, but need not be.

Suitably modulated AC electrical power is supplied by conductors 22 toconductive coatings 16 to cause the piezoelectric elements 15 to providea desired focussed acoustic energy output.

In accordance with a preferred embodiment of the present invention animaging ultrasonic transducer subassembly 23 is incorporated withintransducer 10 and typically comprises a piezoelectric element 24 havingconductive surfaces 26 associated with opposite surfaces thereof.Suitably modulated AC electrical power is supplied by conductors 32 toconductive surfaces 26 in order to cause the piezoelectric element 24 toprovide an acoustic energy output. Conductors 32, coupled to surfaces26, also provide an imaging output from imaging ultrasonic transducersubassembly 23.

It is appreciated that any suitable commercially available ultrasonictransducer may be employed or alternatively, imaging ultrasonictransducer subassembly 23 may be eliminated.

It is further appreciated that various types of ultrasonic transducers10 may be employed. For example, such transducers may include multiplepiezoelectric elements, multilayered piezoelectric elements andpiezoelectric elements of various shapes and sizes arranged in a phasearray.

In a preferred embodiment of the present invention shown in FIG. 1, theultrasonic energy generator and director are combined in transducer 10.Alternatively, the functions of generating ultrasonic energy andfocussing such energy may be provided by distinct devices.

In accordance with a preferred embodiment of the present invention, askin temperature sensor 34, such as an infrared sensor, may be mountedalongside imaging ultrasonic transducer subassembly 23. Further inaccordance with a preferred embodiment of the present invention atransducer temperature sensor 36, such as a thermocouple, may also bemounted alongside imaging ultrasonic transducer subassembly 23.

Ultrasonic transducer 10 preferably receives suitably modulatedelectrical power from a power source and modulator assembly 40, formingpart of a control subsystem 42. Control subsystem 42 also typicallyincludes a lipolysis control computer 44, having associated therewith acamera 46, such as a video camera, and a display 48. A preferredembodiment of power source and modulator assembly 40 is illustrated inFIG. 2 and described hereinbelow. Ultrasonic transducer 10 is preferablypositioned automatically or semi-automatically as by an X-Y-Zpositioning assembly 49. Alternatively, ultrasonic transducer 10 may bepositioned at desired positions by an operator.

In accordance with a preferred embodiment of the present invention,camera 46 is operative for imaging a portion of the body on whichlipolysis is to be performed. A picture of the portion of the patient'sbody viewed by the camera is preferably displayed in real time ondisplay 48.

An operator may designate the outline of a region containing adiposetissue. In accordance with one embodiment of the present invention,designation of this region is effected by an operator marking the skinof a patient with an outline 50, which outline is imaged by camera 46and displayed by display 48 and is also employed by the lipolysiscontrol computer 44 for controlling the application of ultrasonic energyto locations within the region. A computer calculated representation ofthe outline may also be displayed on display 48, as designated byreference numeral 52. Alternatively, the operator may make a virtualmarking on the skin, such as by using a digitizer (not shown), whichalso may provide computer calculated outline representation 52 ondisplay 48.

In addition to the outline representation 52, the functionality of thesystem of the present invention preferably also employs a plurality ofmarkers 54 which are typically located outside the region containingadipose tissue, but may be located inside the region designated byoutline 50. Markers 54 are visually sensible markers, which are clearlyseen by camera 46, captured by camera 46 and displayed on display 48.Markers 54 may be natural anatomic markers, such as distinct portions ofthe body or alternatively artificial markers such as colored stickers.These markers are preferably employed to assist the system in dealingwith deformation of the region nominally defined by outline 50 due tomovement and reorientation of the body. Preferably, the transducer 10also bears a visible marker 56 which is also captured by camera 46 anddisplayed on display 48.

Markers 54 and 56 are typically processed by computer 44 and may bedisplayed on display 48 as respective computed marker representations 58and 60 on display 48.

FIG. 1 illustrates the transducer 10 being positioned on the body over alocation within the region containing adipose tissue. Blocks designatedby reference numerals 62 and 64 show typical portions of a regioncontaining adipose tissue, respectively before and after lipolysis inaccordance with a preferred embodiment of the invention. It is seen froma comparison of blocks 62 and 64 that, in accordance with a preferredembodiment of the present invention, within the region containingadipose tissue, the adipose tissue, designated by reference numeral 66,is lysed, while non-adipose tissue, such as connective tissue,designated by reference numeral 68, is not lysed.

Reference is now FIG. 2, which is a simplified block diagramillustration of a preferred power source and modulator assembly 40 (FIG.1), showing a pattern of variation of ultrasonic pressure over time inaccordance with a preferred embodiment of the present invention. As seenin FIG. 2, the power source and modulator assembly 40 preferablycomprises a signal generator 100 which provides a time varying signalwhich is modulated so as to have a series of relatively high amplitudeportions 102 separated in time by a series of typically relatively lowamplitude portions 104. Each relatively high amplitude portion 102preferably corresponds to a cavitation period and preferably has adecreasing amplitude over time.

Preferably the relationship between the time durations of portions 102and portions 104 is such as to provide a duty cycle between 1:2 and1:250, more preferably between 1:5 and 1:30 and most preferably between1:10 and 1:20.

Preferably, the output of signal generator 100 has a frequency in arange of 50 KHz-1000 KHz, more preferably between 100 KHz-500 KHz andmost preferably between 150 KHz-300 KHz.

The output of signal generator 100 is preferably provided to a suitablepower amplifier 106, which outputs via impedance matching circuitry 108to an input of ultrasonic transducer 10 (FIG. 1), which converts theelectrical signal received thereby to a corresponding ultrasonic energyoutput. As seen in FIG. 2, the ultrasonic energy output comprises a timevarying signal which is modulated correspondingly to the output ofsignal generator 100 so as to having a series of relatively highamplitude portions 112, corresponding to portions 102, separated in timeby a series of typically relatively low amplitude portions 114,corresponding to portions 104.

Each relatively high amplitude portion 102 preferably corresponds to acavitation period and has an amplitude at a target volume 12 (FIG. 1) inthe body which exceeds a cavitation maintaining threshold 120 andpreferably has a decreasing amplitude over time. At least an initialpulse of each relatively high amplitude portion 112 has an amplitude atthe target volume 12, which also exceeds a cavitation initiationthreshold 122.

Relatively low amplitude portions 114 have an amplitude which lies belowboth thresholds 120 and 122.

Preferably the relationship between the time durations of portions 112and portions 114 is such as to provide a duty cycle between 1:2 and1:250, more preferably between 1:5 and 1:30 and most preferably between1:10 and 1:20.

Preferably, the ultrasonic energy output of ultrasonic transducer 10 hasa frequency in a range of 50 KHz-1000 KHz, more preferably between 100KHz-500 KHz and most preferably between 150 KHz-300 KHz.

Preferably, each high amplitude portion 112 is comprised of between 2and 1000 sequential cycles at an amplitude above the cavitationmaintaining threshold 120, more preferably between 25 and 500 sequentialcycles at an amplitude above the cavitation maintaining threshold 120and most preferably between 100 and 300 sequential cycles at anamplitude above the cavitation maintaining threshold 120.

Reference is now made to FIGS. 3A and 3B, which are simplified pictorialillustrations of the appearance of an operator interface display duringnormal operation and faulty operation respectively. As seen in FIG. 3A,during normal operation, display 48 typically shows a plurality oftarget volumes 12 (FIG. 1) within a calculated target region 200,typically delimited by outline representation 52 (FIG. 1). Additionally,display 48 preferably provides one or more pre-programmed performancemessages 202 and status messages 203.

It is seen the various target volumes 12 are shown with differentshading in order to indicate their treatment status. For example,unshaded target volumes, here designated by reference numerals 204 havealready experienced lipolysis. A blackened target volume 12, designatedby reference numeral 205 is the target volume next in line forlipolysis. A partially shaded target volume 206 typically represents atarget volume which has been insufficiently treated to achieve completelipolysis, typically due to an insufficient treatment duration.

Other types of target volumes, such as those not to be treated due toinsufficient presence of adipose tissue therein or for other reasons,may be designated by suitable colors or other designations, and are hereindicated by reference numerals 208 and 210.

Typical performance messages 202 may include “CAVITATION IN PROCESS” and“FAT LYSED IN THIS VOLUME”. Typical status messages 203 may include anindication of the power level, the operating frequency, the number oftarget volumes 12 within the calculated target region 200 and the numberof target volumes 12 which remain to undergo lipolysis.

Display 48 also preferably includes an graphical cross sectionalindication 212 derived from an ultrasonic image preferably provided byimaging ultrasonic transducer subassembly 23 (FIG. 1). Indication 212preferably indicates various tissues in the body in cross section andshows the target volumes 12 in relation thereto. In accordance with apreferred embodiment of the present invention, indication 212 may alsoprovide a visually sensible indication of cavitation within the targetvolume 12.

Turning to FIG. 3B, it is seen that during abnormal operation, display48 provides pre-programmed warning messages 214.

Typical warning messages may include “BAD ACOUSTIC CONTACT”,“TEMPERATURE TOO HIGH”. The “TEMPERATURE TOO HIGH” message typicallyrelates to the skin tissue, although it may alternatively oradditionally relate to other tissue inside or outside of the targetvolume or in transducer 10 (FIG. 1).

Reference is now made to FIG. 4, which illustrates an ultrasoniclipolysis system constructed and operative in accordance with apreferred embodiment of the present invention. As described hereinabovewith reference to FIG. 1 and as seen in FIG. 4, the ultrasonic lipolysissystem comprises a lipolysis control computer 44 which outputs to adisplay 48. Lipolysis control computer 44 preferably receives inputsfrom video camera 46 (FIG. 1) and from a temperature measurement unit300, which receives temperature threshold settings as well as inputsfrom skin temperature sensor 34 (FIG. 1) and transducer temperaturesensor 36 (FIG. 1). Temperature measurement unit 300 preferably comparesthe outputs of both sensors 34 and 36 with appropriate thresholdsettings and provides an indication to lipolysis control computer 44 ofexceedance of either threshold.

Lipolysis control computer 44 also preferably receives an input from anacoustic contact monitoring unit 302, which in turn preferably receivesan input from a transducer electrical properties measurement unit 304.Transducer electrical properties measurement unit 304 preferablymonitors the output of power source and modulator assembly 40 (FIG. 1)to ultrasonic therapeutic transducer 13.

An output of transducer electrical properties measurement unit 304 ispreferably also supplied to a power meter 306, which provides an outputto the lipolysis control computer 44 and a feedback output to powersource and modulator assembly 40.

Lipolysis control computer 44 also preferably receives inputs fromcavitation detection functionality 308, tissue layer identificationfunctionality 310 and lysed adipose tissue identification functionality312, all of which receive inputs from ultrasonic reflection analysisfunctionality 314. Ultrasonic reflection analysis functionality 314receives ultrasonic imaging inputs from an ultrasonic imaging subsystem316, which operates ultrasonic imaging transducer 23 (FIG. 1).

Lipolysis control computer 44 provides outputs to power source andmodulator assembly 40, for operating ultrasonic therapeutic transducer13, and to ultrasonic imaging subsystem 316, for operating ultrasonicimaging transducer 23. A positioning control unit 318 also receives anoutput from lipolysis control computer 44 for driving X-Y-Z positioningassembly 49 (FIG. 1) in order to correctly position transducer 10, whichincludes ultrasonic therapeutic transducer 13 and ultrasonic imagingtransducer 23.

Reference is now made to FIGS. 5A, 5B and 5C, which are together asimplified flowchart illustrating operator steps in carrying outlipolysis in accordance with a preferred embodiment of the presentinvention. As seen in FIG. 4A, initially an operator preferably draws anoutline 50 (FIG. 1) on a patient's body. Preferably, the operator alsoadheres stereotactic markers 54 (FIG. 1) to the patient's body andplaces transducer 10, bearing marker 56, at a desired location withinoutline 50.

Camera 46 (FIG. 1) captures outline 50 and markers 54 and 56.Preferably, outline 50 and markers 54 and 56 are displayed on display 48in real time. The output of camera 46 is also preferably supplied to amemory associated with lipolysis control computer 44 (FIG. 1).

A computerized tracking functionality preferably embodied in lipolysiscontrol computer 44 preferably employs the output of camera 46 forcomputing outline representation 52, which may be displayed for theoperator on display 48. The computerized tracking functionality alsopreferably computes coordinates of target volumes for lipolysistreatment, as well as adding up the total volume of tissue sought toundergo lipolysis.

Preferably, the operator confirms the locations of markers 54 and 56 ondisplay 48 and the computerized tracking functionality calculatescorresponding marker representations 58 and 60.

In accordance with a preferred embodiment of the present invention thecomputerized tracking functionality employs markers 54 and markerrepresentations 58 for continuously maintaining registration of outline50 with respect to outline representation 52, and thus of target volumes12 with respect to the patient's body, notwithstanding movements of thepatients body during treatment, such as due to breathing or any othermovements, such as the patient leaving and returning to the treatmentlocation.

The computerized tracking functionality selects an initial target volumeto be treated and positioning control unit 318 (FIG. 4), computes therequired repositioning of transducer 10. X-Y-Z positioning assembly 49repositions transducer 10 to overlie the selected target volume.

Referring additionally to FIG. 5B, it is seen that followingrepositioning of transducer 10, the lipolysis control computer 44confirms accurate positioning of transducer 10 with respect to theselected target volume. The ultrasonic imaging subsystem 316 (FIG. 4)operates ultrasonic imaging transducer 23, causing it to provide anultrasonic reflection analysis functionality 314 for analysis.

Based on an output from ultrasonic reflection analysis functionality314, the thicknesses of the various tissue layers of the patient aredetermined. Upon receiving an indication of the tissue layerthicknesses, an operator may approve the selected target volume andactivates the power source and modulator assembly 40 (FIG. 1).

Turning additionally to FIG. 5C, it is seen that the followingfunctionalities take place:

Transducer electrical properties measurement unit 304 provides an outputto acoustic contact monitoring unit 302, which determines whethersufficient acoustic contact with the patient is present, preferably byanalyzing the current and voltage at therapeutic transducer 13.

Transducer electrical properties measurement unit 304 provides an outputto power meter 306, which computes the average electrical power receivedby the therapeutic transducer 13. If the average electrical powerreceived by the therapeutic transducer 13 exceeds a predeterminedthreshold, operation of the power source and modulator assembly 40 maybe automatically terminated.

Skin temperature sensor 34 measures the current temperature of the skinat transducer 10 and supplies it to temperature measurement unit 300,which compares the skin temperature to the threshold temperature.Similarly, transducer temperature sensor 36 measures the currenttemperature at transducer 10 and supplies it to temperature measurementunit 300, which compares the transducer temperature to the thresholdtemperature. The outputs of temperature measurement unit 300 aresupplied to lipolysis control computer 44.

The ultrasonic imaging subsystem 316 operates ultrasonic imagingtransducer 23 and receives an imaging output, which is analyzed byultrasonic reflection analysis functionality 314. The result of thisanalysis is employed for cavitation detection and a cavitation detectionoutput is supplied to lipolysis control computer 44.

Should any of the following four conditions occur, the power source andmodulator assembly 40 automatically terminates operation of therapeutictransducer 13. Should none of the following conditions occur, theautomatic operation of power source and modulator assembly 40 continues:

-   1. Acoustic contact is insufficient.-   2. Skin temperature exceeds threshold temperature level.-   3. Transducer 13 temperature exceeds threshold temperature level.-   4. Cavitation is not detected.

Returning to FIG. 5B, it is noted that during automatic operation ofpower source and modulator assembly 40, video camera 46 preferablyrecords the target region and notes whether the transducer 10 remainedstationary during the entire treatment duration of the selected targetvolume 12. If so, and if none of the aforesaid four conditions tookplace, lipolysis control computer 44 confirms that the selected targetvolume was treated. The computerized tracking functionality of lipolysiscontrol computer 44 then proposes a further target volume 12 to betreated.

If, however, the transducer 10 did not remain stationary for asufficient duration, the selected target volume is designated bylipolysis control computer 44 as having been insufficiently treated.

It is appreciated that by using multiple transducers multiplicity oftarget volumes can be treated at various time patterns such assequential time patterns or partially overlapping time patterns.

It is also appreciated that the multiplicity of target volumes may alsooverlap in space or partially overlap in space.

The currently available best mode of the computational trackingfunctionality is set forth in Appendix A, includes the following steps:

-   1) Provide a PC computer, such as an Intel-based Pentium III 800 MHz    computer with Microsoft Windows 2000 operating system, a hard disk    with a minimal capacity of 10 GB, 1 available PCI slot and a 17″    computer screen.-   2) Matrox Orion Frame Grabber Hardware installation/configuration:    -   a) Remove/Disable the VGA board present in the PC computer.    -   b) Place the Matrox Orion Frame Grabber board available from        Matrox (1055 boul. St-Regis, Dorval, Quebec Canada H9P 2T4) into        an available PCI slot in the PC computer.    -   c) Under Microsoft Windows 2000, on booting the computer,        Microsoft Windows′ Plug-and-Play system detects a new Multimedia        Video Device and requests to assign it a driver. At this point,        click Cancel.    -   d) Install the JAI CV-S3200 DSP Surveillance Color CCD Camera        available from JAI America Inc., 23046 Avenida de la Carlota,        Suite 450, Laguna Hills, Calif. 92653 United States and connect        to the Matrox Orion Framer Grabber.    -   e) Set the computer screen impedance switches, red, green, and        blue inputs to 75 ohms.    -   f) Set the computer screen synchronization inputs to high        impedance and external sync mode.    -   g) Connect the computer screen to Matrox Orion's 15-pin female        VGA output connector (DB-15).-   3) Matrox MIL-Lite software (version 6.1) installation:    -   a) Run the Matrox MIL-Lite setup.exe program and follow the        default prompts .    -   b) Run the Matrix Expansion Pack (version 1.0).    -   c) Choose “PAL-YC mode of grabbing” when prompted    -   d) Establish the RS-232 serial communication between the PC and        the JAI camera by registering and installing the “JAI Camera        ActiveX object”-   4) Track Software Installation:    -   a) Create the following respective directories:        -   1) <Track root>—a root directory for Track project        -   2) <Track root>\Src—contains source code files        -   3) <Track root>\Debug—contains an executable file for Track            project        -   4) <Track root>\Images—contains BMP files for debugging the            interior region detection process.        -   5) <Track root>\Log—contains log files and BMP image of the            scene        -   6) <Track root>\Timing—contains timing data files for            debugging    -   b) Copy the file TRACKOBJ.HEX in the \apndx-A folder stored in        the appended CD-ROM into a temporary directory.    -   c) Unhex the computer listing TRACKOBJ.HEX using HEX IT V1.8 or        greater by John Augustine, 3129 Earl St., Laureldale, Pa. 19605        creating file TRACKOBJ.ZIP    -   d) Decompress the file TRACKOBJ.ZIP using WINZIP version 6.2 or        greater, extracting all files into a temporary directory        essentially extracting the following file objects:        -   1) CAMERADLG.OBJ        -   2) DISPLAYFUNCS.OBJ        -   3) IMAGEPROC.OBJ        -   4) INTERIORREGION.OBJ        -   5) MARKERS.OBJ        -   6) NODES.OBJ        -   7) PARAMETERSDLG.OBJ        -   8) STDAFX.OBJ        -   9) TRACK.OBJ        -   10) TRACK.RES        -   11) TRACKDLG.OBJ        -   12) TRANSDUCER.OBJ        -   13) UTILS.OBJ        -   14) VIDEOMATROX.OBJ    -   e) Compile the Object code stored in the temporary directory        created in step 4 d using Microsoft Visual C++ compiler version        6.0 The resulting application is created: TRACK.EXE    -   f) To run the Track software, execute the program TRACK.EXE and        follow the on-line help to operate the program.

It will be appreciated by persons skilled in the art that the presentinvention is not limited by what has been particularly shown anddescribed hereinabove. Rather the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove as well as variations and modifications whichwould occur to persons skilled in the art upon reading the specificationand which are not in the prior art.

1. A method for lysing adipose tissue comprising the steps of: Directingfocused ultrasonic energy at a target volume containing both adiposetissue and non-adipose tissue in a region of the body containing adiposetissue; and modulating said focused ultrasonic energy so as toselectively lyse at least most of said adipose tissue in said targetvolume and not lyse non-adipose tissue in said target volume whichreceives said ultrasonic energy.
 2. A method for lysing adipose tissueaccording to claim 1 and wherein said directing focused ultrasonicenergy generally prevents lysis of tissue outside of said target volume.3. A method for lysing adipose tissue according to claim 1 and alsocomprising: ultrasonic imaging of said region at least partiallyconcurrently with directing said focused ultrasonic energy at saidtarget volume.
 4. A method for lysing adipose tissue according to claim1 and wherein said directing comprises positioning at least oneultrasonic transducer relative to said body in order to direct saidfocused ultrasonic energy at said target volume.
 5. A method for lysingadipose tissue according to claim 1 and wherein said directing comprisesvarying the focus of at least one ultrasonic transducer in order todirect said focused ultrasonic energy at said target volume.
 6. A methodfor lysing adipose tissue according to claim 5 and wherein varying thefocus changes the volume of said target volume.
 7. A method for lysingadipose tissue according to claim 5 and wherein varying the focuschanges the distance of said target volume from said at least oneultrasonic transducer.
 8. A method for lysing adipose tissue accordingto claim 3 and wherein said directing comprises positioning at least oneultrasonic transducer relative to said body in order to direct saidfocused ultrasonic energy at said target volume.
 9. A method for lysingadipose tissue according to claim 3 and wherein said directing comprisesvarying the focus of at least one ultrasonic transducer in order todirect said focused ultrasonic energy at said target volume.
 10. Amethod for lysing adipose tissue according to claim 9 and whereinvarying the focus changes the volume of said target volume.
 11. A methodfor lysing adipose tissue according to claim 9 and wherein varying thefocus changes the distance of said target volume from said at least oneultrasonic transducer.
 12. A method for lysing adipose tissue accordingto claim 1 and also comprising sensing ultrasonic energy coupling to anexternal surface of said body adjacent said target volume.
 13. A methodfor lysing adipose tissue according to claim 1 and also comprisingsensing of cavitation at said target volume.
 14. A method for lysingadipose tissue according to claim 3 and also comprising sensingultrasonic energy coupling to an external surface of said body adjacentsaid target volume.
 15. A method for lysing adipose tissue according toclaim 3 and also comprising sensing of cavitation at said target volume.16. A method according to claim 1 and wherein said directing takes placefrom an ultrasonic transducer located outside of the body.
 17. A methodaccording to claim 3 and wherein said directing takes place from anultrasonic transducer located outside of the body.
 18. A methodaccording to claim 1 and wherein said ultrasonic energy has a frequencyin a range of 50 KHz-1000 KHz.
 19. A method according to claim 1 andwherein said ultrasonic energy has a frequency in a range of 100 KHz-500KHz.
 20. A method according to claim 1 and wherein said ultrasonicenergy has a frequency in a range of 150 KHz300 KHz.
 21. A methodaccording to claim 1 and wherein said modulating provides a duty cyclebetween 1:2 and 1:250.
 22. A method according to claim 1 and whereinsaid modulating provides a duty cycle between 1:5 and 1:30.
 23. A methodaccording to claim 1 and wherein said modulating provides a duty cyclebetween 1:10 and 1:20.
 24. A method according to claim 20 and whereinsaid modulating provides a duty cycle between 1:10 and 1:20.
 25. Amethod according to claim 1 and wherein said modulating provides between2 and 1000 sequential cycles at an amplitude above a cavitationthreshold.
 26. A method according to claim 1 and wherein said modulatingprovides between 25 and 500 sequential cycles at an amplitude above acavitation threshold.
 27. A method according to claim 1 and wherein saidmodulating provides between 100 and 300 sequential cycles at anamplitude above a cavitation threshold.
 28. A method according to claim20 and wherein said modulating provides between 100 and 300 sequentialcycles at an amplitude above a cavitation threshold.
 29. A methodaccording to claim 24 and wherein said modulating provides between 100and 300 sequential cycles at an amplitude above a cavitation threshold.30. A method according to claim 1 and wherein said modulating comprisesmodulating the amplitude of said ultrasonic energy over time.
 31. Amethod according to claim 3 and wherein said ultrasonic energy has afrequency in a range of 50 KHz-1000 KHz.
 32. A method according to claim3 and wherein said ultrasonic energy has a frequency in a range of 100KHz-500 KHz.
 33. A method according to claim 3 and wherein saidultrasonic energy has a frequency in a range of 150 KHz-300 KHz.
 34. Amethod according to claim 3 and wherein said modulating provides a dutycycle between 1:2 and 1:250.
 35. A method according to claim 3 andwherein said modulating provides a duty cycle between 1:5 and 1:30. 36.A method according to claim 3 and wherein said modulating provides aduty cycle between 1:10 and 1:20.
 37. A method according to claim 33 andwherein said modulating provides a duty cycle between 1:10 and 1:20. 38.A method according to claim 3 and wherein said modulating providesbetween 2 and 1000 sequential cycles at an amplitude above a cavitationthreshold.
 39. A method according to claim 3 and wherein said modulatingprovides between 25 and 500 sequential cycles at an amplitude above acavitation threshold.
 40. A method according to claim 3 and wherein saidmodulating provides between 100 and 300 sequential cycles at anamplitude above a cavitation threshold.
 41. A method according to claim33 and wherein said modulating provides between 100 and 300 sequentialcycles at an amplitude above a cavitation threshold.
 42. A methodaccording to claim 37 and wherein said modulating provides between 100and 300 sequential cycles at an amplitude above a cavitation threshold.43. A method according to claim 3 and wherein said modulating comprisesmodulating the amplitude of said ultrasonic energy over time.
 44. Amethod for lysing adipose tissue comprising the steps of: directingultrasonic energy at a multiplicity of target volumes within a region ofa body, which target volumes contain adipose tissue and non-adiposetissue, thereby to selectively lyse at least most of said adipose tissuewithin said target volumes and generally not lyse non-adipose tissuewithin said target volumes which receives said ultrasonic energy; andcomputerized tracking of said multiplicity of target volumesnotwithstanding movement of said body.
 45. A method for lysing adiposetissue according to claim 44 and wherein said computerized trackingincludes sensing changes in the position of markings on said body andemploying sensed changes for tracking the positions of said targetvolumes in said body.
 46. Apparatus for lysing adipose tissuecomprising: A focused ultrasonic energy director, directing focusedultrasonic energy at a target volume in a region of a body containingadipose and non-adipose tissue; and a modulator, cooperating with saidenergy director to produce a focused ultrasonic energy such that atleast most of said adipose tissue within said target volume is lysed andnon-adipose tissue within said target volume which receives saidultrasonic energy is not lysed.
 47. Apparatus for lysing adipose tissueaccording to claim 46 and wherein said director generally prevents lysisof tissue outside of said target volume.
 48. Apparatus for lysingadipose tissue according to claim 46 and also comprising: an ultrasonicimager providing ultrasonic imaging of said region at least partiallyconcurrently with directing said focused ultrasonic energy at saidtarget volume.
 49. Apparatus for lysing adipose tissue according toclaim 46 and wherein said director comprises a positioner, positioningat least one ultrasonic transducer relative to said body in order todirect said focused ultrasonic energy at said target volume. 50.Apparatus for lysing adipose tissue according to claim 46 and whereinsaid director varies the focus of at least one ultrasonic transducer inorder to direct said focused ultrasonic energy at said target volume.51. Apparatus for lysing adipose tissue according to claim 50 andwherein varying the focus changes the volume of said target volume. 52.Apparatus for lysing adipose tissue according to claim 50, and whereinvarying the focus changes the distance of said target volume from saidat least one ultrasonic transducer.
 53. Apparatus for lysing adiposetissue according to claim 48 and wherein said director positions atleast one ultrasonic transducer relative to said body in order to directsaid focused ultrasonic energy at said target volume.
 54. Apparatus forlysing adipose tissue according to claim 48 and wherein said directorvaries the focus of at least one ultrasonic transducer in order todirect said focused ultrasonic energy at said target volume. 55.Apparatus for lysing adipose tissue according to claim 54 and whereinvarying the focus changes the volume of said target volume. 56.Apparatus for lysing adipose tissue according to claim 54 and whereinvarying the focus changes the distance of said target volume from saidat least one ultrasonic transducer.
 57. Apparatus for lysing adiposetissue according to claim 46 and also comprising a sensor, sensingultrasonic energy coupling to an external surface of said body adjacentsaid target volume.
 58. Apparatus for lysing adipose tissue according toclaim 46 and also comprising a sensor, sensing of cavitation at saidtarget volume.
 59. Apparatus for lysing adipose tissue according toclaim 48 and also comprising a sensor, sensing ultrasonic energycoupling to an external surface of said body adjacent said targetvolume.
 60. Apparatus for lysing adipose tissue according to claim 48and also comprising a sensor, sensing of cavitation at said targetvolume.
 61. Apparatus according to claim 46 and wherein said directorcomprises an ultrasonic transducer located outside of the body. 62.Apparatus according to claim 48 and wherein said director comprises anultrasonic transducer located outside of the body.
 63. Apparatusaccording to claim 46 and wherein said ultrasonic energy has a frequencyin a range of 50 KHz-1000 KHz.
 64. Apparatus according to claim 46 andwherein said ultrasonic energy has a frequency in a range of 100 KHz-500KHz.
 65. Apparatus according to claim and wherein said ultrasonic energyhas a frequency in a range of 150 KHz-300 KHz.
 66. Apparatus accordingto claim 46 and wherein said modulator provides a duty cycle between 1:2and 1:250.
 67. Apparatus according to claim 46 and wherein saidmodulator provides a duty cycle between 1:5 and 1:30.
 68. Apparatusaccording to claim 46 and wherein said modulator provides a duty cyclebetween 1:10 and 1:20.
 69. Apparatus according to claim 65 and whereinsaid modulator provides a duty cycle between 1:10 and 1:20. 70.Apparatus according to claim 46 and wherein said modulator providesbetween 2 and 1000 sequential cycles at an amplitude above a cavitationthreshold.
 71. Apparatus according to claim 46 and wherein saidmodulator provides between 25 and 500 sequential cycles at an amplitudeabove a cavitation threshold.
 72. Apparatus according to claim 46 andwherein said modulator provides between 100 and 300 sequential cycles atan amplitude above a cavitation threshold.
 73. Apparatus according toclaim 65 and wherein said modulator provides between 100 and 300sequential cycles at an amplitude above a cavitation threshold. 74.Apparatus according to claim 69 and wherein said modulator providesbetween 100 and 300 sequential cycles at an amplitude above a cavitationthreshold.
 75. Apparatus according to claim 46 and wherein saidmodulator modulates the amplitude of said ultrasonic energy over time.76. Apparatus according to claim 48 and wherein said ultrasonic energyhas a frequency in a range of 50 KHz-1000 KHz.
 77. Apparatus accordingto claim 48 and wherein said ultrasonic energy has a frequency in arange of 100 KHz-500 KHz.
 78. Apparatus according to claim 48 andwherein said ultrasonic energy has a frequency in a range of 150 KHz-300KHz.
 79. Apparatus according to claim 48 and wherein said modulatorprovides a duty cycle between 1:2 and 1:250.
 80. Apparatus according toclaim 48 and wherein said modulator provides a duty cycle between 1:5and 1:30.
 81. Apparatus according to claim 48 and wherein said modulatorprovides a duty cycle between 1:10 and 1:20.
 82. Apparatus according toclaim 78 and wherein said modulator provides a duty cycle between 1:10and 1:20.
 83. Apparatus according to claim 48 and wherein said modulatorprovides between 2 and 1000 sequential cycles at an amplitude above acavitation threshold.
 84. Apparatus according to claim 48 and whereinsaid modulator provides between 25 and 500 sequential cycles at anamplitude above a cavitation threshold.
 85. Apparatus according to claim48 and wherein said modulator provides between 100 and 300 sequentialcycles at an amplitude above a cavitation threshold.
 86. Apparatusaccording to claim 78 and wherein said modulator provides between 100and 300 sequential cycles at an amplitude above a cavitation threshold.87. Apparatus according to claim 82 and wherein said modulator providesbetween 100 and 300 sequential cycles at an amplitude above a cavitationthreshold.
 88. Apparatus according to claim 48 and wherein saidmodulator modulates the amplitude of said ultrasonic energy over time.89. Apparatus for lysing adipose tissue comprising: A director,directing ultrasonic energy at a miltiplicity of target volumes within aregion of a body, which target volumes contain adipose tissue andnon-adipose tissue, a modulator,—cooperating with said energy directorto produce focused ultrasonic energy—thereby to lyse at least most ofsaid adipose tissue within said target volumes and not lyse non-adiposetissue within said target volumes which receives said ultrasonic energy;and computerized tracking functionality providing computerized trackingof said miltiplicity of target volumes notwithstanding movement of saidbody.
 90. Apparatus for lysing adipose tissue according to claim 89 andwherein said computerized tracking functionality is operative to sensechanges in the position of markings on said body and to employ sensedchanges for tracking the positions of said target volumes in said body.